Prospective, Randomized Controlled Trial (smartNTx)

Prospective, Randomized Controlled Trial to Investigate Additional Interventional Telemedical Management Versus Standard Aftercare in Kidney Transplant Recipients (smartNTx)

The smartNTx trial: Prospective, randomized controlled trial (RCT) to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipients (KTR).

STUDY PURPOSE: To demonstrate that additional interventional telemedical management will lead to a higher chance for long-term graft survival, increase adherence, quality of life (QoL), and reduce complications and healthcare costs after kidney transplantation.

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplant Rejection
• Intervention / Treatment: Combination product: Additional interventional telemedical management

Detailed Description

This is a 1-year, prospective, randomized, 2-armed, parallel group multicenter trial in 3 German Kidney Transplant Centers (KTCs) to demonstrate that additional and continuous interventional telemedical management will lead to a better composite endpoint of 7 key outcome variables (hospitalizations, length of hospitalization, development of a de-novo donor specific antibody (DSA), medication adherence, tacrolimus intra-patient variability, blood pressure control and renal function after kidney transplantation). All patients will receive the same routine posttransplant aftercare. Patients in the interventional arm will receive a predefined additional telemedical management including regular telemedicine visits and automatic data transfer (e.g. vital signs, well-being, medication plan laboratory data and chat) between the patient at home and KTC through a certified smartphone application (comjoo business solutions GmbH, Berlin, Germany). Furthermore, home nephrologists of patients in the interventional arm are invited to participate in automatic data transfer of key variables (such as vital signs, laboratory data) with KTC. A separate telemedicine team will constantly review the incoming data according to a predefined protocol and eventually contact the patient and/or the home nephrologist in order to start appropriate interventions.

• Study Type: Interventional
• Enrollment (Estimated): 384
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario Schiffer, Prof. Dr.; Phone Number: +49(0)9131-85-39002; Email: med4@uk-erlangen.de

Study Locations

• Germany
  • Essen, Germany
    • Not yet recruiting
    • University Hospital Essen
    • Contact: Lars Pape, Dr. med.; Phone Number: 0201 723 2150; Email: lars.pape@uk-essen.de
    • Principal Investigator: Lars Pape, Dr. med.
  • Bavaria
    • Berlin, Bavaria, Germany, 10117
      • Recruiting
      • charite universitatsmedizin Berlin
      • Contact: Klemens Budde, Prof. Dr.; Phone Number: +49 30 450 514 002; Email: nephrologie-telemedizin@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Kidney transplantation within last 12 months
• Treatment with tacrolimus
• Routine aftercare planned at KTC
• Ability to use a smartphone or tablet or with help of someone close by
• For children < 12 years parents have to take over the use of the smartphone
• Patients who are willing and able to participate in the study and from whom written informed consent has been obtained prior to study participation or pediatric patients with parenteral consent
• Ability to communicate in German or English
• Adequate and stable renal function (eGFR > 30 ml/min, Proteinuria < 1g/g creatinine) eGFR will be determined according to CKD-EPI for adults [81] or Schwartz formula for children [82]

Exclusion Criteria:

• Patient with mental dysfunction or inability to comply with the study protocol or pediatric patients whose parents cannot comply with the study protocol
• Any significant diseases or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination findings that would in the opinion of the investigator preclude the patient from participating in the study
• History of alcohol or drug abuse with less than 6 months of sobriety
• Participation in any other interventional clinical trial less than 1 month before participation in this study
• Patients who have been institutionalized by official or court order
• Patients with a combined kidney transplant or multi-organ recipients (other solid organ (e.g. pancreas) or bone marrow)
• Presence of DSA with MFI > 1000 at time of transplantation
• Recurrence of underlying kidney disease (e.g. focal segmental glomerulosclerosis (FSGS) or atypical hemolytic uremic syndrome (aHUS)
• Patient with active malignancy post-transplant with the exception of local, non-invasive, fully excised, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ
• Patients with clinically symptomatic congestive heart failure (CHF) or symptomatic coronary artery disease
• Patients with documented (either by serology and/or nuclear acid testing (NAT) clinically active infections (e.g. with a known hepatitis B (HBV), hepatitis C (HCV), HIV, CMV or BK virus infection).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group "Additional telemedical management"; Patients in the interventional arm will receive a predefined additional telemedical management including regular telemedicine visits and automatic data transfer (e.g. vital signs, well-being, medication plan laboratory data and chat) between the patient at home and KTC through a certified smartphone application.	Combination product: Additional interventional telemedical management; Predefined additional telemedical management including regular telemedicine visits and automatic data transfer (e.g. vital signs, well-being, medication plan laboratory data and chat) between the patient at home and KTC through a certified smartphone application.
No Intervention: Control group "Routine posttransplant aftercare"; Patients in the control group will receive routine posttransplant aftercare.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence	According to BAASIS questionnaire at month 12	12 months
Unplanned hospitalizations	yes/no during study period	12 months
Length of unplanned hospitalization	More/less than 10 nights during study period	12 months
Development of de-novo DSA	yes/no at month 12	12 months
Tacrolimus intra-patient variability	Above/below 30% between month 6 to 12	12 months
Blood pressure control	normal/abnormal 24h-RR profile at month 12	12 months
Renal function	suboptimal renal function (eGFR < 45 ml/min at month 12	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced graft losses (result evalution)	Documentation of graft losses at all visits - Month 3, 6, 9, 12	12 months
Better prognosis of the iBox score (result evalution)	Documentation of the prognosis of the AI during visit 5, month 12	12 months
Improvement in quality of life (result evalution)	Change in quality of life over 12 months (PROMIS 29 questionnaire) at month 0, 3, 6, 9, 12 (visit 1 to 5).	12 months
Improving disease management (process evalution)	Change in disease management over 12 months (PAM13 questionnaire) at month 0, 3, 6, 9, 12 (visit 1 to 5)	12 months
Acceptance of the new restoration among patients (process evalution)	Survey using established questionnaires and rating and satisfaction with care (own development) at Visit 4, 5 (month 9; 12)	12 months
Acceptance of the new restoration among service providers (process evalution)	Survey using established and newly developed questionnaires, as well as analyzes for usage behavior, including Grade and Assess Predictive tools. Benefit assessment of the data- and AI-supported Decision support (in-house development).	12 months

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborators: Charite University, Berlin, Germany; University Hospital, Essen
• Investigators: Principal Investigator: Mario Schiffer, Prof. Dr., Uniklinikum Erlangen

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Aftercare; Telemedical Management
• Other Study ID Numbers: 01NVF21116; 0673 (Other Identifier: Universitätsklinikum Erlangen)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No